Download entremed commences panzem ncd phase 2 study in

FOR IMMEDIATE RELEASE:
September 12, 2006
7:00 a.m. ET
CONTACT:
Ginny Dunn
Associate Director, Corporate
Communications & Investor Relations
EntreMed, Inc.
240.864.2643
ENTREMED COMMENCES PANZEM® NCD PHASE 2 STUDY
IN PROSTATE CANCER
ROCKVILLE, MD, September 12, 2006 -- EntreMed, Inc. (NASDAQ: ENMD), a clinical-stage
pharmaceutical company developing therapeutics for the treatment of cancer and inflammatory diseases,
today announced commencement of a multi-center Phase 2 study with its lead clinical-stage drug
candidate, Panzem® NCD (2ME2 or 2-methoxyestradiol), in patients with hormone-refractory prostate
cancer (HRPC). Initially, the study will be conducted by the University of Wisconsin Comprehensive
Cancer Center, as a member of the Prostate Cancer Clinical Trial Consortium, with additional sites joining
during the third quarter. Dr. Glenn Liu, Assistant Professor of Medicine, University of Wisconsin, will
serve as the principal investigator.
Patients with evidence of progressive metastatic disease or known metastatic disease and rising
PSA, during or after treatment with a taxane-based regimen, are expected to be enrolled in the study.
The purpose of the study will be to assess the antitumor activity, safety, and pharmacokinetics of
Panzem® NCD in patients with HRPC. This study will expand the results obtained to date on the use of
Panzem® in men with HRPC.
Dr. Liu commented on commencement of the study, “A major problem with assessing
treatment benefit in prostate cancer is the difficulty of evaluating responses in patients with bony
metastasis. In these patients, the utility of measuring a PSA response may or may not be clinically
meaningful using a novel agent like Panzem® NCD. For this study, we chose to assess a valuable
clinical endpoint (progression-free survival), as well as a pharmacodynamic endpoint using current
imaging technology. This will also allow us to fully evaluate the benefits of potential new anticancer
agents like Panzem® NCD.”
Carolyn F. Sidor, M.D., M.B.A., EntreMed Vice President and Chief Medical Officer,
commented, “HRPC has been a focus of our development plan for Panzem® and working with the
Prostate Cancer Clinical Trial Consortium allows us to continue this effort at multiple sites well-known
for their expertise in prostate cancer trials. Very few options exist for patients with taxane-refractory
HRPC and most chemotherapeutics are associated with considerable toxicity. Our goal is to provide
patients with an option that may stabilize their disease without significant side effects.”
About Prostate Cancer
Prostate cancer is one of the most common cancers in men and accounts for about 10% of
cancer-related deaths in men. The American Cancer Society estimates that approximately 230,000
new cases will be diagnosed in the United States in 2006, resulting in approximately 27,000 deaths.
Chances of developing prostate cancer increase in men over 50 years of age. Prostate cancer occurs
when cells within the prostate gland grow uncontrollably, creating small tumors.
About EntreMed
EntreMed, Inc. (NASDAQ: ENMD) is a clinical-stage pharmaceutical company developing
therapeutic candidates primarily for the treatment of cancer and inflammation. Panzem® (2methoxyestradiol or 2ME2), the Company's lead drug candidate, is currently in Phase 2 clinical trials
for cancer, as well as in preclinical development for rheumatoid arthritis. MKC-1, an oral cell cycle
regulator, is in Phase 2 studies for metastatic breast cancer. ENMD-1198, a novel tubulin binding
agent, is also in Phase 1 studies in advanced cancers. EntreMed's goal is to develop and commercialize
new compounds based on the Company's expertise in angiogenesis, cell cycle regulation and
inflammation -- processes vital to the treatment of cancer and other diseases, such as rheumatoid
arthritis. Additional information about EntreMed is available on the Company’s website at
www.entremed.com and in various filings with the Securities and Exchange Commission.
Forward Looking Statements
This release contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act with respect to the outlook for expectations for future financial or business
performance (including the timing of royalty revenues and future R&D expenditures), strategies,
expectations and goals. Forward-looking statements are subject to numerous assumptions, risks and
uncertainties, which change over time. Forward-looking statements speak only as of the date they are
made, and no duty to update forward-looking statements is assumed. Actual results could differ
materially from those currently anticipated due to a number of factors, including those set forth in
Securities and Exchange Commission filings under "Risk Factors," including risks relating to the need
for additional capital and the uncertainty of additional funding; variations in actual sales of Thalomid®,
risks associated with the integration of Miikana and its product candidates; the early-stage products
under development; results in preclinical models are not necessarily indicative of clinical results,
uncertainties relating to preclinical and clinical trials; success in the clinical development of any
products; dependence on third parties; future capital needs; and risks relating to the commercialization,
if any, of the Company's proposed products (such as marketing, safety, regulatory, patent, product
liability, supply, competition and other risks).
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